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Internal and Emergency Medicine

, Volume 13, Issue 7, pp 1059–1067 | Cite as

Variations in clinical management of non-vitamin K antagonist oral anticoagulants in patients with atrial fibrillation according to different equations for estimating renal function

Post hoc analysis of a prospective cohort
  • Vincenzo Livio Malavasi
  • Daniele Pettorelli
  • Elisa Fantecchi
  • Cristina Zoccali
  • Giuliana Laronga
  • Tommaso Trenti
  • Gregory Yoke Hong Lip
  • Giuseppe Boriani
IM - ORIGINAL

Abstract

Prescription of non-vitamin K antagonist oral anticoagulants (NOACs) requires an assessment of renal function (RF) and the Cockcroft–Gault (CG) equation is traditionally recommended. The objective of the study was to evaluate the potential changes in NOACs management using different equations for estimating RF. In a post hoc analysis of a prospective cohort of patients with atrial fibrillation, we considered different equations: (1) CG for creatinine clearance (CrCl), (2) modification of diet in renal disease (MDRD), (3) CKD-EPI, (4) Berlin Initiative Study 1 (BIS-1) and (5) full age spectrum (FAS), for glomerular filtration rate (GFR). RF was classified according to CrCl in three categories: severely depressed (SD-RF) < 30 ml/min; moderately depressed (MD-RF) 30–49 ml/min; preserved/mildly depressed (P-RF) ≥ 50 ml/min. Concordances in the assignments were analyzed. A population of 402 patients (61.2% males, age 72 ± 11) was categorized according to CrCl: 12 patients (2.9%) as SD-RF, 81 (20.1%) as MD-RF, 309 (76.8%) as P-RF. A potential change in NOACs management could occur using GFR equations rather than CrCl in 16.9% of patients using MDRD formula, in 11.7% using BIS-1, in 14.7% using CKD-EPI and in 12.9% using the FAS equation. Important changes in RF estimates were more frequent in patients aged ≥ 75, but also BMI had a meaningful impact. Use of equations estimating GFR instead of the Cockcroft–Gault equation may result in changes in NOACs management in 12–17% of patients. In the elderly ≥ 75, more pronounced changes in RF classification are detectable according to different equations and NOACs dosing should be further investigated.

Keywords

Anticoagulation Atrial fibrillation Non-vitamin K antagonists oral anticoagulants Renal function Glomerular filtration rate Creatinine clearance 

Notes

Compliance with ethical standards

Conflict of interest

None.

Statements on human and animal rights

The study had been approved by the appropriate institutional research ethics committee. All procedures performed in the study involving human participants were in accordance with the ethical standards of the institutional and/or national research committee and with the 1964 Helsinki declaration and its later amendments or comparable ethical standards.

Informed consent

Informed consent was obtained from all individual participants included in the study.

Supplementary material

11739_2018_1857_MOESM1_ESM.docx (437 kb)
Supplementary material 1 (DOCX 437 kb)

References

  1. 1.
    Kirchhof P, Benussi S, Kotecha D et al (2016) 2016 ESC Guidelines for the management of atrial fibrillation developed in collaboration with EACTS. The Task Force for the management of atrial fibrillation of the European Society of Cardiology (ESC), Developed with the special contribution of the European Heart Rhythm Association (EHRA) of the ESC, endorsed by the European Stroke Organisation. Eur Heart JGoogle Scholar
  2. 2.
    Hart RG, Pearce LA, Aguilar MI (2007) Meta-analysis: antithrombotic therapy to prevent stroke in patients who have nonvalvular atrial fibrillation. Ann Intern Med 146:857–867CrossRefGoogle Scholar
  3. 3.
    Connolly SJ, Ezekowitz MD, Yusuf S et al (2009) Dabigatran versus warfarin in patients with atrial fibrillation. N Engl J Med 361:1139–1151CrossRefGoogle Scholar
  4. 4.
    Patel MR, Mahaffey KW, Garg J et al (2011) Rivaroxaban versus warfarin in nonvalvular atrial fibrillation. N Engl J Med 365:883–891CrossRefGoogle Scholar
  5. 5.
    Granger CB, Alexander JH, McMurray JJ et al (2011) Apixaban versus warfarin in patients with atrial fibrillation. N Engl J Med 365:981–992CrossRefGoogle Scholar
  6. 6.
    Giugliano RP, Ruff CT, Braunwald E et al (2013) Edoxaban versus warfarin in patients with atrial fibrillation. N Engl J Med 369:2093–2104CrossRefGoogle Scholar
  7. 7.
    Ruff CT, Giugliano RP, Braunwald E et al (2014) Comparison of the efficacy and safety of new oral anticoagulants with warfarin in patients with atrial fibrillation: a meta-analysis of randomised trials. Lancet 383:955–962CrossRefGoogle Scholar
  8. 8.
    Lip G, Freedman B, De Caterina R, Potpara TS (2017) Stroke prevention in atrial fibrillation: Past, present and future. Comparing the guidelines and practical decision-making. Thromb Haemost 117:1230–1239CrossRefGoogle Scholar
  9. 9.
    Camm AJ, Lip GY, De Caterina R et al (2012) 2012 focused update of the ESC Guidelines for the management of atrial fibrillation: an update of the 2010 ESC Guidelines for the management of atrial fibrillation. Developed with the special contribution of the European Heart Rhythm Association. Eur Heart J 33:2719–2747CrossRefGoogle Scholar
  10. 10.
    Devereaux PJ, Yang H, Yusuf S et al (2008) Effects of extended-release metoprolol succinate in patients undergoing non-cardiac surgery (POISE trial): a randomised controlled trial. Lancet 371:1839–1847CrossRefGoogle Scholar
  11. 11.
    Heidbuchel H, Verhamme P, Alings M et al (2015) Updated European Heart Rhythm Association Practical Guide on the use of non-vitamin K antagonist anticoagulants in patients with non-valvular atrial fibrillation. Europace 17:1467–1507CrossRefGoogle Scholar
  12. 12.
    Stevens LA, Coresh J, Greene T, Levey AS (2006) Assessing kidney function–measured and estimated glomerular filtration rate. N Engl J Med 354:2473–2483CrossRefGoogle Scholar
  13. 13.
    (2013) KDIGO 2012 clinical practice guideline for the evaluation and management of chronic kidney disease. Kidney international 3:1–150Google Scholar
  14. 14.
    Lip GYH, Collet JP, Caterina R et al (2017) Antithrombotic therapy in atrial fibrillation associated with valvular heart disease: a joint consensus document from the European Heart Rhythm Association (EHRA) and European Society of Cardiology Working Group on Thrombosis, endorsed by the ESC Working Group on Valvular Heart Disease, Cardiac Arrhythmia Society of Southern Africa (CASSA), Heart Rhythm Society (HRS), Asia Pacific Heart Rhythm Society (APHRS), South African Heart (SA Heart) Association and Sociedad Latinoamericana de Estimulación Cardíaca y Electrofisiología (SOLEACE). Europace 19:1757–1758CrossRefGoogle Scholar
  15. 15.
    Cockcroft DW, Gault MH (1976) Prediction of creatinine clearance from serum creatinine. Nephron 16:31–41CrossRefGoogle Scholar
  16. 16.
    Levey AS, Bosch JP, Lewis JB, Greene T, Rogers N, Roth D (1999) A more accurate method to estimate glomerular filtration rate from serum creatinine: a new prediction equation. Modification of Diet in Renal Disease Study Group. Ann Intern Med 130:461–470CrossRefGoogle Scholar
  17. 17.
    Levey AS, Stevens LA, Schmid CH et al (2009) A new equation to estimate glomerular filtration rate. Ann Intern Med 150:604–612CrossRefGoogle Scholar
  18. 18.
    Schaeffner ES, Ebert N, Delanaye P et al (2012) Two novel equations to estimate kidney function in persons aged 70 years or older. Ann Intern Med 157:471–481CrossRefGoogle Scholar
  19. 19.
    Pottel H, Hoste L, Dubourg L et al (2016) An estimated glomerular filtration rate equation for the full age spectrum. Nephrol Dial Transplant 31:798–806CrossRefGoogle Scholar
  20. 20.
    Rostoker G, Andrivet P, Pham I, Griuncelli M, Adnot S (2007) A modified Cockcroft-Gault formula taking into account the body surface area gives a more accurate estimation of the glomerular filtration rate. J Nephrol 20:576–585PubMedGoogle Scholar
  21. 21.
    Viera AJ, Garrett JM (2005) Understanding interobserver agreement: the kappa statistic. Fam Med 37:360–363Google Scholar
  22. 22.
    Shrout PE, Fleiss JL (1979) Intraclass correlations: uses in assessing rater reliability. Psychol Bull 86:420–428CrossRefGoogle Scholar
  23. 23.
    (1998) Food and Drug Administration: guidance for industry: pharmacokinetics in patients with impaired renal function— study design, data analysis, and impact on dosing and labeling. Department of Health and Human Services, Rockville, May. https://www.fda.gov/downloads/drugs/guidances/ucm204959.pdf
  24. 24.
    Cirillo M, Anastasio P, De Santo NG (2005) Relationship of gender, age, and body mass index to errors in predicted kidney function. Nephrol Dial Transplant 20:1791–1798CrossRefGoogle Scholar
  25. 25.
    Stevens LA, Nolin TD, Richardson MM et al (2009) Comparison of drug dosing recommendations based on measured GFR and kidney function estimating equations. Am J Kidney Dis 54:33–42CrossRefGoogle Scholar
  26. 26.
    Michels WM, Grootendorst DC, Verduijn M, Elliott EG, Dekker FW, Krediet RT (2010) Performance of the Cockcroft-Gault, MDRD, and new CKD-EPI formulas in relation to GFR, age, and body size. Clin J Am Soc Nephrol 5:1003–1009CrossRefGoogle Scholar
  27. 27.
    Boriani G, Savelieva I, Dan GA et al (2015) Chronic kidney disease in patients with cardiac rhythm disturbances or implantable electrical devices: clinical significance and implications for decision making-a position paper of the European Heart Rhythm Association endorsed by the Heart Rhythm Society and the Asia Pacific Heart Rhythm Society. Europace 17:1169–1196CrossRefGoogle Scholar
  28. 28.
    January CT, Wann LS, Alpert JS et al (2014) 2014 AHA/ACC/HRS guideline for the management of patients with atrial fibrillation: a report of the American College of Cardiology/American Heart Association Task Force on Practice Guidelines and the Heart Rhythm Society. J Am Coll Cardiol 64:e1–76CrossRefGoogle Scholar
  29. 29.
    Kakkar AK, Mueller I, Bassand JP et al (2013) Risk profiles and antithrombotic treatment of patients newly diagnosed with atrial fibrillation at risk of stroke: perspectives from the international, observational, prospective GARFIELD registry. PLoS One 8:e63479CrossRefGoogle Scholar
  30. 30.
    Olesen JB, Lip GY, Kamper AL et al (2012) Stroke and bleeding in atrial fibrillation with chronic kidney disease. N Engl J Med 367:625–635CrossRefGoogle Scholar
  31. 31.
    Boriani G, Laroche C, Diemberger I et al (2016) Glomerular filtration rate in patients with atrial fibrillation and 1-year outcomes. Sci Rep 6:30271CrossRefGoogle Scholar
  32. 32.
    Fanikos J, Burnett AE, Mahan CE, Dobesh PP (2017) Renal function considerations for stroke prevention in atrial fibrillation. Am J Med 130(9):1015–1023CrossRefGoogle Scholar
  33. 33.
    Lip GY, Andreotti F, Fauchier L et al (2011) Bleeding risk assessment and management in atrial fibrillation patients: a position document from the European Heart Rhythm Association, endorsed by the European Society of Cardiology Working Group on Thrombosis. Europace 13:723–746CrossRefGoogle Scholar
  34. 34.
    Manzano-Fernández S, Andreu-Cayuelas JM, Marín F et al (2015) Comparison of estimated glomerular filtration rate equations for dosing new oral anticoagulants in patients with atrial fibrillation. Rev Esp Cardiol (Engl Ed) 68:497–504CrossRefGoogle Scholar
  35. 35.
    NKDEP (2010) NKDEP. National Kidney Disease Education Program. Chronic kidney disease and drug dosing: information for providers. http://www.nkdep.nih.gov/professionals/CKD_DrugDosing_508.pdf
  36. 36.
    (2010) US Food and Drug Administration (2010). Draft guidance for industry: pharmacokinetics in patient with impaired kidney function—study design DA, and impact on dosing and labeling. http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM204959.pdf
  37. 37.
    Levey AS, Coresh J, Balk E et al (2003) National Kidney Foundation practice guidelines for chronic kidney disease: evaluation, classification, and stratification. Ann Intern Med 139:137–147CrossRefGoogle Scholar
  38. 38.
    Hawkins NM, Jhund PS, Pozzi A et al (2016) Severity of renal impairment in patients with heart failure and atrial fibrillation: implications for non-vitamin K antagonist oral anticoagulant dose adjustment. Eur J Heart Fail 18:1162–1171CrossRefGoogle Scholar
  39. 39.
    Stevens LA, Levey AS (2009) Measured GFR as a confirmatory test for estimated GFR. J Am Soc Nephrol 20:2305–2313CrossRefGoogle Scholar

Copyright information

© SIMI 2018

Authors and Affiliations

  • Vincenzo Livio Malavasi
    • 1
  • Daniele Pettorelli
    • 1
  • Elisa Fantecchi
    • 1
  • Cristina Zoccali
    • 1
  • Giuliana Laronga
    • 1
  • Tommaso Trenti
    • 2
  • Gregory Yoke Hong Lip
    • 3
  • Giuseppe Boriani
    • 1
  1. 1.Cardiology Division, Department of Diagnostics, Clinical and Public Health MedicineUniversity of Modena and Reggio EmiliaModenaItaly
  2. 2.Laboratory Medicine DepartmentOspedale Civile Sant’Agostino EstenseModenaItaly
  3. 3.Institute of Cardiovascular SciencesUniversity of BirminghamBirminghamUK

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